ESSURE
Report
- Report Number
- 2951250-2017-05149
- Event Type
- Injury
- Date Received
- October 19, 2017
- Date of Event
- January 1, 2012
- Report Date
- June 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE,") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 4 ((B)(6) 2003, (B)(6) 2005, (B)(6) 2008, (B)(6) 2009, MULTIGRAVIDA, MISCARRIAGE, PRETERM LABOR, ACUTE CYSTITIS, ACUTE VULVITIS, DYSFUNCTIONAL UTERINE BLEEDING, URINARY FREQUENCY, VAGINITIS BACTERIAL, UTI, VAGINAL ITCHING, VAGINAL ODOR, LEFT LOWER QUADRANT PAIN, BACTERIAL VAGINOSIS AND CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS, WITH OBSTRUCTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, COLD SORES, SEXUALLY TRANSMITTED DISEASE, OVARIAN CYST, ABDOMINAL PAIN, ACNE, ESOPHAGEAL REFLUX, LUMBAR SCOLIOSIS AND VITAMIN B12 DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR BIRTH CONTROL, ANTIBIOTICS FOR VAGINAL DISCHARGE AS WELL AS CYANOCOBALAMIN (VITAMIN B12) SINCE 2017, IBUPROFEN AND SALBUTAMOL (ALBUTEROL) SINCE 2014. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN SEPTEMBER 2011, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). IN JANUARY 2012, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"), ALOPECIA ("HAIR LOSS,") AND VERTIGO ("VERTIGO"). IN FEBRUARY 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). IN JANUARY 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), TOOTH DISORDER ("DENTAL PROBLEMS"), FATIGUE ("FATIGUE,"), NAUSEA ("NAUSEA,"), ANXIETY ("ANXIETY,"), DEPRESSION ("DEPRESSION,"), RASH ("RASHES,") AND WEIGHT INCREASED ("WEIGHT GAIN."). ON (B)(6) 2015, 3 YEARS 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN JANUARY 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE,"). IN 2016, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("ALLERGIC REACTION IN THE FORM OF RASHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), VITAMIN B12 DEFICIENCY ("B 12 ISSUES,") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SURGERY (OPERATIVE LAPAROSCOPY, REMOVAL BILATERALLY, CAUTERIZATION OF FALLOPIAN TUBES), SURGERY (OPERATIVE LAPAROSCOPY, REMOVAL BILATERALLY, CAUTERIZATION OF FALLOPIAN TUBES) AND SURGERY (NOVASURE ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, ALOPECIA, DEPRESSION AND RASH HAD RESOLVED, THE DEVICE DISLOCATION, DYSPAREUNIA, DERMATITIS ALLERGIC, MENSTRUAL DISORDER, VAGINAL DISCHARGE, MOOD SWINGS, VITAMIN B12 DEFICIENCY, TOOTH DISORDER, FATIGUE, IRRITABLE BOWEL SYNDROME, VERTIGO, NAUSEA, MIGRAINE, HEADACHE, ANXIETY, WEIGHT INCREASED AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA AND BACTERIAL VAGINOSIS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACTERIAL VAGINOSIS, DEPRESSION, DERMATITIS ALLERGIC, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VITAMIN B12 DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE CATHETER HAS PLACED INTO THE LEFT FALLOPIAN TUBE SHOWS 5 COILS AND RIGHT SHOWS 3 COILS EXTENDING INTO THE INTRAUTERINE CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.7 KG/SQM. HYSTEROSALPINGOGRAM - ON 1-NOV-2011: TOTAL BILATERAL OCCLUSION . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: RASHES, PELVIC PAIN, PAINFUL INTERCOURSE, HAIR LOSS, ANXIETY, IRRITABLE BOWEL SYNDROME, MIGRAINES, HEADACHES, VITAMIN B12 DEFICIENCY, DEPRESSION, VAGINAL DISCHARGE, MENORRHAGIA,VAGINAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-2018: PFS RECEIVED AN EVENT " ABDOMINAL PAIN" IS ADDED. OUTCOME OF EVENTS " CRAMPING AND INFECTIONS" ARE RECOVERING.CONCOMITANT CONDITION AND DRUG ARE ADDED. REPORTER INFORMATION ADDED. TREATMENT DRUG ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE,") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 4 ((B)(6) 2003, (B)(6) 2005, (B)(6) 2008, (B)(6) 2009.), MULTIGRAVIDA, MISCARRIAGE, PRETERM LABOR, ACUTE CYSTITIS, ACUTE VULVITIS, DYSFUNCTIONAL UTERINE BLEEDING, URINARY FREQUENCY, VAGINITIS BACTERIAL, UTI, VAGINAL ITCHING, VAGINAL ODOR, LEFT LOWER QUADRANT PAIN, BACTERIAL VAGINOSIS AND CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS, WITH OBSTRUCTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, COLD SORES, SEXUALLY TRANSMITTED DISEASE, OVARIAN CYST, ABDOMINAL PAIN, ACNE, ESOPHAGEAL REFLUX, LUMBAR SCOLIOSIS AND VITAMIN B12 DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR BIRTH CONTROL, ANTIBIOTICS FOR VAGINAL DISCHARGE AS WELL AS CYANOCOBALAMIN (VITAMIN B12) SINCE 2017, IBUPROFEN AND SALBUTAMOL (ALBUTEROL) SINCE 2014. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"), ALOPECIA ("HAIR LOSS,") AND VERTIGO ("VERTIGO"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), TOOTH DISORDER ("DENTAL PROBLEMS"), FATIGUE ("FATIGUE,"), NAUSEA ("NAUSEA,"), ANXIETY ("ANXIETY,"), DEPRESSION ("DEPRESSION,"), RASH ("RASHES,") AND WEIGHT INCREASED ("WEIGHT GAIN."). ON (B)(6) 2015, 3 YEARS 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE,"). IN 2016, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("ALLERGIC REACTION IN THE FORM OF RASHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), VITAMIN B12 DEFICIENCY ("B 12 ISSUES,") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SURGERY (OPERATIVE LAPAROSCOPY, REMOVAL BILATERALLY, CAUTERIZATION OF FALLOPIAN TUBES), SURGERY (OPERATIVE LAPAROSCOPY, REMOVAL BILATERALLY, CAUTERIZATION OF FALLOPIAN TUBES) AND SURGERY (NOVASURE ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, ALOPECIA, DEPRESSION AND RASH HAD RESOLVED, THE DEVICE DISLOCATION, DYSPAREUNIA, DERMATITIS ALLERGIC, MENSTRUAL DISORDER, VAGINAL DISCHARGE, MOOD SWINGS, VITAMIN B12 DEFICIENCY, TOOTH DISORDER, FATIGUE, IRRITABLE BOWEL SYNDROME, VERTIGO, NAUSEA, MIGRAINE, HEADACHE, ANXIETY, WEIGHT INCREASED AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA AND BACTERIAL VAGINOSIS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACTERIAL VAGINOSIS, DEPRESSION, DERMATITIS ALLERGIC, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VITAMIN B12 DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE CATHETER HAS PLACED INTO THE LEFT FALLOPIAN TUBE SHOWS 5 COILS AND RIGHT SHOWS 3 COILS EXTENDING INTO THE INTRAUTERINE CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: RASHES, PELVIC PAIN, PAINFUL INTERCOURSE, HAIR LOSS, ANXIETY, IRRITABLE BOWEL SYNDROME, MIGRAINES, HEADACHES, VITAMIN B12 DEFICIENCY, DEPRESSION, VAGINAL DISCHARGE, MENORRHAGIA,VAGINAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE,") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 4 ((B)(6) 2003, (B)(6) 2005, (B)(6) 2008, (B)(6) 2009.), GRAVIDA II, MISCARRIAGE, PRETERM LABOR, ACUTE CYSTITIS, ACUTE VULVITIS, DYSFUNCTIONAL UTERINE BLEEDING, URINARY FREQUENCY, VAGINITIS BACTERIAL, UTI, VAGINAL ITCHING, VAGINAL ODOR, LEFT LOWER QUADRANT PAIN, BACTERIAL VAGINOSIS AND CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS, WITH OBSTRUCTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, COLD SORES, SEXUALLY TRANSMITTED DISEASE, OVARIAN CYST, ABDOMINAL PAIN, ACNE AND ESOPHAGEAL REFLUX. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR BIRTH CONTROL AND ANTIBIOTICS FOR VAGINAL DISCHARGE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"), ALOPECIA ("HAIR LOSS,") AND VERTIGO ("VERTIGO"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), TOOTH DISORDER ("DENTAL PROBLEMS"), FATIGUE ("FATIGUE,"), NAUSEA ("NAUSEA,"), ANXIETY ("ANXIETY,"), DEPRESSION ("DEPRESSION,"), RASH ("RASHES,") AND WEIGHT INCREASED ("WEIGHT GAIN."). ON (B)(6) 2015, 3 YEARS 11 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE,"). IN 2016, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("ALLERGIC REACTION IN THE FORM OF RASHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION") AND VITAMIN B12 DEFICIENCY ("B 12 ISSUES,"). THE PATIENT WAS TREATED WITH OPERATIVE LAPAROSCOPY, REMOVAL BILATERALLY, CAUTERIZATION OF FALLOPIAN TUBES AND NOVASURE ENDOMETRIAL ABLATION.. ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, ALOPECIA, DEPRESSION AND RASH HAD RESOLVED AND THE DEVICE DISLOCATION, DYSPAREUNIA, DYSMENORRHOEA, DERMATITIS ALLERGIC, MENSTRUAL DISORDER, VAGINAL DISCHARGE, MOOD SWINGS, BACTERIAL VAGINOSIS, VITAMIN B12 DEFICIENCY, TOOTH DISORDER, FATIGUE, IRRITABLE BOWEL SYNDROME, VERTIGO, NAUSEA, MIGRAINE, HEADACHE, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BACTERIAL VAGINOSIS, DEPRESSION, DERMATITIS ALLERGIC, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VITAMIN B12 DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE CATHETER HAS PLACED INTO THE LEFT FALLOPIAN TUBE SHOWS 5 COILS AND RIGHT SHOWS 3 COILS EXTENDING INTO THE INTRAUTERINE CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.7 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2011: TOTAL BILATERAL OCCLUSION . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: RASHES, PELVIC PAIN, PAINFUL INTERCOURSE, HAIR LOSS, ANXIETY, IRRITABLE BOWEL SYNDROME, MIGRAINES, HEADACHES, VITAMIN B12 DEFICIENCY, DEPRESSION, VAGINAL DISCHARGE, MENORRHAGIA,VAGINAL BLEEDING. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-MAY-2018: PFS RECEIVED- NEW EVENT ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), MOOD SWINGS, BACTERIAL VAGINOSIS, B12 DEFICIENCY, DENTAL PROBLEMS, DYSMENORRHEA(CRAMPING), FATIGUE, IRRITABLE BOWEL SYNDROME, HAIR LOSS, VERTIGO, NAUSEA, MIGRATION OF ESSURE DEVICE, MIGRAINES, HEADACHES, ANXIETY, DEPRESSION, RASHES, VAGINAL DISCHARGE, WEIGHT GAIN WERE ADDED. NEW REPORTER,PATIENT INFORMATION AND LOT NUMBER WERE ADDED. CONCOMITANT CONDITIONS,HISTORICAL CONDITIONS AND CONCOMITANT MEDICATION WERE ADDED. ON 22-MAY-2018: MEDICAL RECORDS RECEIVED- NEW REPORTERS AND CONCOMITANT MEDICATION WERE ADDED. CONCOMITANT AND HISTORICAL CONDITIONS WERE ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/ PAIN"), EMBEDDED DEVICE ("MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE : MYOMETRIUM") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 4 (B)(6) 2003, (B)(6) 2005, (B)(6) 2008, (B)(6) 2009 MULTIGRAVIDA, MISCARRIAGE, PRETERM LABOR, ACUTE CYSTITIS, ACUTE VULVITIS, DYSFUNCTIONAL UTERINE BLEEDING, URINARY FREQUENCY, VAGINITIS BACTERIAL, UTI, VAGINAL ITCHING, VAGINAL ODOR, LEFT LOWER QUADRANT PAIN, BACTERIAL VAGINOSIS AND CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS, WITH OBSTRUCTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, COLD SORES, SEXUALLY TRANSMITTED DISEASE, OVARIAN CYST, ABDOMINAL PAIN, ACNE, ESOPHAGEAL REFLUX, LUMBAR SCOLIOSIS AND VITAMIN B12 DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA) FOR BIRTH CONTROL, ANTIBIOTICS FOR VAGINAL DISCHARGE AS WELL AS CYANOCOBALAMIN (VITAMIN B12) SINCE 2017, IBUPROFEN, SALBUTAMOL (ALBUTEROL) SINCE 2014 AND TYLOX (PERCOCET [OXYCODONE HYDROCHLORIDE,OXYCODONE TEREPHTHALATE,PARACETAMOL]). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN SEPTEMBER 2011, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). ON (B)(6) 2012, 4 MONTHS 16 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN JANUARY 2012, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"), ALOPECIA ("HAIR LOSS,") AND VERTIGO ("VERTIGO"). IN FEBRUARY 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). IN JANUARY 2014, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"), FATIGUE ("FATIGUE,"), NAUSEA ("NAUSEA,"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION : MENTAL ANGUISH"), DEPRESSION ("DEPRESSION/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION : DEPRESSION"), RASH ("RASHES,") AND WEIGHT INCREASED ("WEIGHT GAIN."). IN AUGUST 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE,") AND BACTERIAL VULVOVAGINITIS ("INFECTION ( BLADDER/URINARY TRACT/VAGINAL) TYPE : BACTERIAL VAGINITIS"). IN 2016, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DERMATITIS ALLERGIC ("ALLERGIC REACTION IN THE FORM OF RASHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), VITAMIN B12 DEFICIENCY ("B 12 ISSUES,") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (NOVASURE ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, ALOPECIA, DEPRESSION AND RASH HAD RESOLVED, THE EMBEDDED DEVICE, DYSPAREUNIA, DERMATITIS ALLERGIC, MENSTRUAL DISORDER, VAGINAL DISCHARGE, MOOD SWINGS, VITAMIN B12 DEFICIENCY, TOOTH DISORDER, FATIGUE, IRRITABLE BOWEL SYNDROME, VERTIGO, NAUSEA, MIGRAINE, HEADACHE, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA, BACTERIAL VAGINOSIS, ABDOMINAL PAIN AND BACTERIAL VULVOVAGINITIS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACTERIAL VAGINOSIS, BACTERIAL VULVOVAGINITIS, DEPRESSION, DERMATITIS ALLERGIC, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VITAMIN B12 DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE CATHETER HAS PLACED INTO THE LEFT FALLOPIAN TUBE SHOWS 5 COILS AND RIGHT SHOWS 3 COILS EXTENDING INTO THE INTRAUTERINE CAVITY. ON 11-DEC-2017, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY WAS DONE. ON, 22-FEB-2013, ABLATION WAS DONE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.7 KG/SQM. HYSTEROSALPINGOGRAM - ON 1-NOV-2011: TOTAL BILATERAL OCCLUSION . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: RASHES, PELVIC PAIN, PAINFUL INTERCOURSE, HAIR LOSS, ANXIETY, IRRITABLE BOWEL SYNDROME, MIGRAINES, HEADACHES, VITAMIN B12 DEFICIENCY, DEPRESSION, VAGINAL DISCHARGE, MENORRHAGIA,VAGINAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-OCT-2018: PLAINTIFF FACT SHEET RECEIVED - PRODUCT INFORMATION UPDATED. NEW EVENT BACTERIAL VAGINITIS ADDED.. OUTCOME OF EVENT ABDOMINAL PAIN UPDATED FROM UNKNOWN TO RECOVERING / RESOLVING. EVENT MIGRATION OF ESSURE DEVICE IS UPDATED TO MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE : MYOMETRIUM. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PAIN'), EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE : MYOMETRIUM') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 863581) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 4 (ON (B)(6) 2003, ON (B)(6) 2005, ON (B)(6) 2008, ON (B)(6) 2009.), MULTIGRAVIDA, MISCARRIAGE, PRETERM LABOR, ACUTE CYSTITIS, ACUTE VULVITIS, DYSFUNCTIONAL UTERINE BLEEDING, URINARY FREQUENCY, VAGINITIS BACTERIAL, UTI, VAGINAL ITCHING, VAGINAL ODOR, LEFT LOWER QUADRANT PAIN, BACTERIAL VAGINOSIS AND CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS, WITH OBSTRUCTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, COLD SORES, SEXUALLY TRANSMITTED DISEASE, OVARIAN CYST, ABDOMINAL PAIN, ACNE, ESOPHAGEAL REFLUX, LUMBAR SCOLIOSIS AND VITAMIN B12 DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FOR BIRTH CONTROL, ANTIBIOTICS FOR VAGINAL DISCHARGE AS WELL AS IBUPROFEN, OXYCODONE HYDROCHLORIDE; PARACETAMOL (PERCOCET), SALBUTAMOL (ALBUTEROL) SINCE 2014 AND VITAMIN B12 NOS SINCE 2017. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 4 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"), ALOPECIA ("HAIR LOSS,") AND VERTIGO ("VERTIGO"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). ON (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"), FATIGUE ("FATIGUE,"), NAUSEA ("NAUSEA,"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION : MENTAL ANGUISH"), DEPRESSION ("DEPRESSION/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION : DEPRESSION") AND RASH ("RASHES,") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN."). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE,") AND BACTERIAL VULVOVAGINITIS ("INFECTION ( BLADDER/URINARY TRACT/VAGINAL) TYPE : BACTERIAL VAGINITIS"). IN 2016, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DERMATITIS ALLERGIC ("ALLERGIC REACTION IN THE FORM OF RASHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), VITAMIN B12 DEFICIENCY ("B 12 ISSUES,") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND NOVASURE ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL DISCHARGE, BACTERIAL VAGINOSIS, ALOPECIA, DEPRESSION, RASH AND BACTERIAL VULVOVAGINITIS HAD RESOLVED, THE EMBEDDED DEVICE, DYSPAREUNIA, DERMATITIS ALLERGIC, MENSTRUAL DISORDER, MOOD SWINGS, VITAMIN B12 DEFICIENCY, TOOTH DISORDER, FATIGUE, IRRITABLE BOWEL SYNDROME, VERTIGO, NAUSEA, MIGRAINE, HEADACHE, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACTERIAL VAGINOSIS, BACTERIAL VULVOVAGINITIS, DEPRESSION, DERMATITIS ALLERGIC, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VITAMIN B12 DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE CATHETER HAS PLACED INTO THE LEFT FALLOPIAN TUBE SHOWS 5 COILS AND RIGHT SHOWS 3 COILS EXTENDING INTO THE INTRAUTERINE CAVITY. DISCREPANCNY NOTED: ON (B)(6) 2017, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY WAS DONE. DATE(S) OF REMOVAL: ON (B)(6) 2017 (DISCREPANCY NOTED) ON, (B)(6) 2013, ABLATION WAS DONE. PATIENT RECEIVED TREATMENT FOR : PAIN , ABNORMAL BLEEDING, MIGRATION , VAGINAL DISCHARGE, BACTERIAL VAGINOSIS , BACTERIAL VAGINITIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.7 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: RASHES, PELVIC PAIN, PAINFUL INTERCOURSE, HAIR LOSS, ANXIETY, IRRITABLE BOWEL SYNDROME, MIGRAINES, HEADACHES, VITAMIN B12 DEFICIENCY, DEPRESSION, VAGINAL DISCHARGE, MENORRHAGIA,VAGINAL BLEEDING. LOT NUMBER: 863581, MANUFACTURE DATE: 2011-05, EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUN-2020: QUALITY-SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PAIN'), EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE : MYOMETRIUM') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 4 ((B)(6) .), MULTIGRAVIDA, MISCARRIAGE, PRETERM LABOR, ACUTE CYSTITIS, ACUTE VULVITIS, DYSFUNCTIONAL UTERINE BLEEDING, URINARY FREQUENCY, VAGINITIS BACTERIAL, UTI, VAGINAL ITCHING, VAGINAL ODOR, LEFT LOWER QUADRANT PAIN, BACTERIAL VAGINOSIS AND CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS, WITH OBSTRUCTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, COLD SORES, SEXUALLY TRANSMITTED DISEASE, OVARIAN CYST, ABDOMINAL PAIN, ACNE, ESOPHAGEAL REFLUX, LUMBAR SCOLIOSIS AND VITAMIN B12 DEFICIENCY. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FOR BIRTH CONTROL, ANTIBIOTICS FOR VAGINAL DISCHARGE AS WELL AS IBUPROFEN, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), SALBUTAMOL (ALBUTEROL) SINCE 2014 AND VITAMIN B12 NOS SINCE 2017. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWINGS"). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 4 MONTHS 16 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IRRITABLE BOWEL SYNDROME"), ALOPECIA ("HAIR LOSS,") AND VERTIGO ("VERTIGO"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES,"). IN (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"), FATIGUE ("FATIGUE,"), NAUSEA ("NAUSEA,"), ANXIETY ("ANXIETY/PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION : MENTAL ANGUISH"), DEPRESSION ("DEPRESSION/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION : DEPRESSION") AND RASH ("RASHES,") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN."). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON (B)(6) 2016, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE,") AND BACTERIAL VULVOVAGINITIS ("INFECTION ( BLADDER/URINARY TRACT/VAGINAL) TYPE : BACTERIAL VAGINITIS"). IN 2016, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DERMATITIS ALLERGIC ("ALLERGIC REACTION IN THE FORM OF RASHES"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"), VITAMIN B12 DEFICIENCY ("B 12 ISSUES,") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND NOVASURE ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL DISCHARGE, BACTERIAL VAGINOSIS, ALOPECIA, DEPRESSION, RASH AND BACTERIAL VULVOVAGINITIS HAD RESOLVED, THE EMBEDDED DEVICE, DYSPAREUNIA, DERMATITIS ALLERGIC, MENSTRUAL DISORDER, MOOD SWINGS, VITAMIN B12 DEFICIENCY, TOOTH DISORDER, FATIGUE, IRRITABLE BOWEL SYNDROME, VERTIGO, NAUSEA, MIGRAINE, HEADACHE, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE DYSMENORRHOEA AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACTERIAL VAGINOSIS, BACTERIAL VULVOVAGINITIS, DEPRESSION, DERMATITIS ALLERGIC, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VERTIGO, VITAMIN B12 DEFICIENCY AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE CATHETER HAS PLACED INTO THE LEFT FALLOPIAN TUBE SHOWS 5 COILS AND RIGHT SHOWS 3 COILS EXTENDING INTO THE INTRAUTERINE CAVITY. DISCREPANCNY NOTED: ON (B)(6) 2017, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY WAS DONE.DATE(S) OF REMOVAL: (B)(6) 2017 (DISCREPANCY NOTED) ON, (B)(6) 2013, ABLATION WAS DONE. PATIENT RECEIVED TREATMENT FOR : PAIN , ABNORMAL BLEEDING, MIGRATION , VAGINAL DISCHARGE, BACTERIAL VAGINOSIS , BACTERIAL VAGINITIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) . HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: RASHES, PELVIC PAIN, PAINFUL INTERCOURSE, HAIR LOSS, ANXIETY, IRRITABLE BOWEL SYNDROME, MIGRAINES, HEADACHES, VITAMIN B12 DEFICIENCY, DEPRESSION, VAGINAL DISCHARGE, MENORRHAGIA,VAGINAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED. EVENT OUTCOME WERE UPDATED TO RECOVERED: VAGINAL DISCHARGE, BACTERIAL VAGINOSIS , BACTERIAL VAGINITIS. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE"), DERMATITIS ALLERGIC ("ALLERGIC REACTION IN THE FORM OF RASHES") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, DERMATITIS ALLERGIC AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DERMATITIS ALLERGIC, DYSPAREUNIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743197 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | ALBUTEROL| ALBUTEROL| ALBUTEROL| ALBUTEROL [SALBUTAMOL]| ALBUTEROL [SALBUTAMOL]| ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| VITAMIN B12| VITAMIN B12| VITAMIN B12| VITAMIN B12 NOS| VITAMIN B12 NOS |